| Primary | Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
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| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.83± 0.17
- OG001-1.07± 0.16
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference. | Mixed Models Analysis | Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment*Week+Baseline*Week,participant random effect. | 0.001 | The a priori threshold for statistical significance was 0.05. | | | | | | 95 | | | | |
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| Secondary | Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase) | This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries. | Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation. | Posted | | Number | | participants | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. | Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase) | Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Secondary | Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase) | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase) | A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6 | C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide. | All randomized participants. | Posted | | Number | | participants | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase) | Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase) | The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
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| Secondary | Number of Participants Who Discontinued During the Acute Phase (by Week 6) | | All randomized participants. | Posted | | Number | | participants | | Baseline through 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). |
| |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase | Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module. | All randomized participants. | Posted | | Number | | participants | | Baseline through 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Secondary | Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase | | All randomized participants. | Posted | | Number | | participants | | Baseline through 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Other Pre-specified | Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase) | Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | milliEq/Liter | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Other Pre-specified | Change From Baseline in Creatinine at Week 6 (Acute Phase) | Change from baseline to acute phase endpoint in laboratory assessment of creatinine. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | milligram/deciliter (mg/dL) | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Other Pre-specified | Change From Baseline in the Platelet Count at Week 6 (Acute Phase) | Change from baseline to acute phase endpoint in laboratory assessment of platelet count. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | Thousand/microliter | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Other Pre-specified | Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase) | Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Other Pre-specified | Change From Baseline in Uric Acid at Week 6 (Acute Phase) | Change from baseline to acute phase endpoint in laboratory assessment of uric acid. | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Secondary | Change From Baseline in Blood Pressure at Week 6 (Acute Phase) | | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
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| Secondary | Change From Baseline in Pulse Rate at Week 6 (Acute Phase) | | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | beats per minute (bpm) | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
| |
| Secondary | Change From Baseline in Weight at Week 6 (Acute Phase) | | Number of randomized participants with baseline and at least 1 post-baseline value. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. | | OG001 | Placebo | Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). |
| |
| Secondary | Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse). | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | units on a scale | | 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
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| Secondary | Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18 | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (end of acute phase/Week 6), Endpoint (Week 18) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
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| Secondary | Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase) | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| |
| Secondary | Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase) | A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| |
| Secondary | Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18 | C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide. | All randomized participants who entered the extension phase. | Posted | | Number | | participants | | 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| |
| Secondary | Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase) | Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase. | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline (6 weeks) through Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| |
| Secondary | Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase) | The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3. | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| |
| Secondary | Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18) | | All participants randomized to placebo in acute phase received duloxetine during the extension phase. | Posted | | Number | | participants | | Baseline (6 weeks) through Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase | Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module. | All randomized participants in the open-label extension phase. | Posted | | Number | | participants | | Baseline (6 weeks) through Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | 60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase). |
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| Secondary | Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase | | All randomized participants in the open-label extension phase. | Posted | | Number | | participants | | Baseline (6 weeks) through Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| | |
| Other Pre-specified | Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | Thousand/microliter | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| | |
| Other Pre-specified | Change From Baseline in Sodium at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | milliEq/Liter | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| | |
| Other Pre-specified | Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | gram/deciliter (g/dL) | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase). |
| | |
| Secondary | Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | 60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase). |
| | |
| Secondary | Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline (6 weeks), endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | 60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase). |
| | |
| Secondary | Change From Baseline in Weight at Week 18 (Open-label Extension Phase) | | Number of randomized participants who entered and had at least 1 non-missing value during extension phase. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline (6 weeks), Endpoint (18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | 60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase). |
| | |